This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease

Mutant-type KRAS tumor at screening

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1

Adequate hematology, renal, hepatic, and coagulation function

Exclusion Criteria:

History or known presence of central nervous system metastases

History of other malignancy

Prior irinotecan-based chemotherapy for advanced/metastatic disease

Prior death receptor agonists, or other systemic IGF-1R agonists in any setting

Uncontrolled cardiovascular disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813605